Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/C...
FDA Device Recall #Z-2011-2025 — Class II — May 28, 2025
Recall Summary
| Recall Number | Z-2011-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 28, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Encore Medical, LP |
| Location | Austin, TX |
| Product Type | Devices |
| Quantity | 200 units |
Product Description
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. Component: NA
Reason for Recall
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Distribution Pattern
At time of quarantine: RFK Medical Inc. Virginia (VA) CE102 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 2 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1 Evolution Medical North Dakota (ND), Minnesota (MN), Colorado (CO), Utah (UT) CE106 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1 506-04-130 5039A1021 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 4 Valor Medical Solutions South Texas (TX) CE118 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 6 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 17 Matrix Orthopedics Surgical Devices Dallas/Fort Worth, TX CE120 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 1 Joint Ventures Medical LLC Wisconsin (WI) CE121 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 24 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1 WHISKEY TRAIL ORTHOPEDICS LLC - AUS Tennessee (TN) CE123 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 8 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 4 McCants Medical, LLC Florida (FL) CE128 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 4 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 2 Florida Direct - FSW Medical Florida (FL) FL001 506-04-118 5033A1020 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm 16 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 14 506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 6 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 72 506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 27 506-04-130 5039A1021 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 65 Great Lakes Medical Illinois (IL) GL108 506-04-118 5033A1020 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm 8 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 6 506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 2 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 14 Certus Medical LLC Indiana (IN) & Michigan (MI) GL112 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 14 506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 17 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 3 506-04-130 5039A1021 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 23 I & S Medical West Virginia (WV) & Kentucky (KY) GL113 506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1 506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 8 Osteo Solutions Ohio (OH), Kentucky (KY), GL114 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 15 506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 16 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 6 506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 32 Procore Medical, LLC North Carolina (NC) MA102 506-04-118 5033A1020 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm 1 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 14 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 2 506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 59 Medsource Rhode Island (RI), Massachusetts (MA) NE131 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 3 506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 12 506-04-126 5037A1017 ALTIVATE REVERSE TORX PER
Lot / Code Information
Lot Code: Item: 506-04-130 GTIN: 00190446829867 Lot/s: 5039A1015 / 5039A1021
Other Recalls from Encore Medical, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1459-2026 | Class II | Brand Name: EMPOWR 3D KNEE Product Name: EMPOW... | Jan 15, 2026 |
| Z-1458-2026 | Class II | Brand Name: Reverse Shoulder Prosthesis (RSP) ... | Jan 15, 2026 |
| Z-1460-2026 | Class II | Brand Name: Reverse Shoulder Prosthesis (RSP) ... | Jan 15, 2026 |
| Z-1233-2026 | Class II | EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: ... | Jan 5, 2026 |
| Z-1234-2026 | Class II | EMPOWR Acetabular System: Liner, 10 degree Hood... | Jan 5, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.